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US 2016/0095846 A1Published application
Sublingual fentanyl spray
AssigneeInsys Pharma, Inc.
InventorsS. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet Kattookaran, Neha Parikh
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Abstract
The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Claims21
A sublingual spray formulation for the treatment of pain comprising:
- (i) from about 0.1% to about 0.8% by weight of fentanyl, a free base or a pharmaceutically acceptable salt thereof, or a derivative thereof;
- (ii) from about 50% to about 60% by weight of ethanol;
- and
- (iii) from about 4% to about 6% by weight of propylene glycol,
- wherein the formulation provides a mean Tmax of about 1.28+/−0.60, is propellant-free and comprises droplets having a mean diameter of at least about 10 microns.
2 more elements
A sublingual spray formulation for the treatment of pain comprising:
- (i) from about 0.1% to about 0.8% by weight of fentanyl, a free base or a pharmaceutically acceptable salt thereof, or a derivative thereof;
- (ii) from about 50% to about 60% by weight of ethanol;
- and
- (iii) from about 4% to about 6% by weight of propylene glycol,
- wherein the formulation provides a mean time to 60% maximum plasma concentration (Tmax) of fentanyl of about 10 minutes, is propellant-free and comprises droplets having a mean diameter of at least about 10 microns and wherein the formulation provides a mean time to the lower limit of quantification (LLOQ) of fentanyl of about 5 minutes.
2 more elements
Dependencies are inferred from the claim text.